Study of the Effect of Testosterone and Estradiol on NP Responses to Acute and Chronic Salt Loading

What Was Tested

In this early phase 1 trial, researchers set out to test Leuprolide.

There is gender dimorphism in cardiovascular risk, with men at higher risk than women.

However, the fundamental basis for the protective effect of female sex remains unclear.

Recent data implicate the natriuretic peptide (NP) system as an important determinant of blood pressure.

It had two arms (groups): Testosterone (other) and Estradiol (other).

The registry classes the interventions as drug.

Who Took Part

It was open to people of any sex aged from 18 years up to 40 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 18-40 years old. No history of hypertension. Male: normal testosterone and free testosterone levels. Female: regular menses, negative pregnancy test, no sex steroid therapy \>/=3 mos.

The full record lists 5 inclusion and 15 exclusion criteria; among the exclusions: on hypertensives, diuretics, or insulin; with diabetes mellitus; prior cardiovascular, liver or renal disease.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Leuprolide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Leuprolide group and the comparison group ran side by side rather than switching.

As a double-blind Leuprolide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2014-06 with completion listed for 2016-02.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: NP levels in men with testosterone patch and low-salt diet (time frame: At day 7 of week of testosterone administration with low-salt diet). NP levels in men with testosterone patch and high-salt diet (time frame: At day 7 of week of testosterone administration with high-salt diet). NP levels in women with estradiol patch and low-salt diet (time frame: At day 7 of week of estradiol administration with low-salt diet).

It also tracked 20 secondary outcomes, for example Plasma Renin Activity (PRA) levels in women on estradiol on low-salt diet, Aldosterone levels in men with testosterone on low-salt diet, Plasma Renin Activity (PRA) levels in women on estradiol on high-salt diet, Plasma Renin Activity (PRA) levels in women on placebo on low-salt diet, Plasma Renin Activity (PRA) levels in women on placebo on high-salt diet and Plasma Renin Activity (PRA) levels in men on testosterone on low-salt diet.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Leuprolide in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, all human trials.